MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 LINER IMPACTOR HEAD 32MM; PROSTHSISHIPHMI-TRUNNIONBEARINGFMORALMTALPOLYACTAL

Catalog Number 71368132

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms the device fractured into two pieces.Both pieces were returned.The device exhibits significant signs of use and wear.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

Event Description

It was reported that, during surgery, a r3 liner impactor head 32mm broke off while inside the patient.All pieces were retrieved.Surgery was completed, after a delay of less than or equal 30 minutes, with a sn back-up device.No harm to the patient or any further complications reported.

• Brand Name: R3 LINER IMPACTOR HEAD 32MM
• Type of Device: PROSTHSISHIPHMI-TRUNNIONBEARINGFMORALMTALPOLYACTAL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 12801067
• MDR Text Key: 282830143
• Report Number: 1020279-2021-08104
• Device Sequence Number: 1
• Product Code: JDH
• UDI-Device Identifier: 03596010599971
• UDI-Public: 3596010599971
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71368132
• Device Lot Number: 09DDS0023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention